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FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
Health Reform: The Latest Twist in the Legal War on Obamacare
From - National Intelligence Report
The Affordable Care Act, aka Obamacare, remains alive but certainly not well. When last we left the melodrama, a federal district court in…
Can a Blood Test Quantify Pain?
From - Diagnostic Testing & Emerging Technologies
A new test could help clinicians objectively measure pain. According to a study published…
OIG Monthly Work Plan Review: March 2019
From - Lab Compliance Advisor
This month, there were 16 new Work Plan items. Three of these may have implications for some labs as…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
Genomic Data Sharing: From Utopian Principle to Practical Reality
From - National Intelligence Report
As a principle, it's hard to take issue with Science's recommendation; but as the article itself notes, actually achieving genomic data sharing remains…